Eerder Erbij: The Path Towards Offering Timely Support for People With Dementia and Their Caregivers

Study Purpose

INTRODUCTION AND RATIONALE.It has been estimated that at least 50% of the home living persons with dementia in the Netherlands receive little or no formal care and support (Zorgstandaard Dementie, 2013). Reasons why persons with dementia and their informal caregivers receive no formal care vary, include absence of diagnosis, denial of illness, embarrassment or the complexity of the care and referral system. A common concern among health care professionals is that by the time the person with dementia or informal caregiver do seek or receive formal care it may be too late. The difficulties at home may already be so severe that there is little that community-based care can do and admission to residential care may follow soon after. Appropriate support at an earlier stage may prevent more serious difficulties and postpone admission to residential care. Therefore, health care professionals are looking for strategies to reach persons with dementia and caregivers in an earlier stage of dementia and encourage them to accept some form of help or support. The rationale of this study is to investigate how persons living with dementia and their close others can be encouraged to accept support and whether support at an early stage is effective in preventing severe deterioration in wellbeing, behavioural difficulties and high care costs later on. OBJECTIVES.

  • - Estimate the effect of EE on caregiver self-efficacy compared to usual care.
  • - Estimate the effect of EE on the total care costs of caregiver and person with dementia compared to usual care.
  • - Estimate the cost-effectiveness and cost-utility of EE compared to usual care.
  • - Perform a process evaluation to monitor delivery of EE and experiences of persons with dementia, caregivers and care professionals.
  • - Explore treatment responsiveness of EE in terms of self-efficacy and quality of life.
STUDY DESIGN.Pragmatic, cluster randomised controlled trial. STUDY POPULATION.Informal caregivers and people with early-stage dementia, who are community dwelling and receive little or no dementia-related formal ADL care. INTERVENTION.The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group. MAIN STUDY PARAMETERS/ENDPOINTS.Primary: self-efficacy. Cost-utility: EQ5D, RUD. Secondary: quality-of-life, caregiver burden. DATA COLLECTION.Measurements consist of questionnaires (total duration is approximately 1 hour; administered at home; take place at baseline, 3, 6, and 12 months).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Informal caregivers can be spouses, relatives, or friends who care for and support the person with dementia without pay.
If the caregiver does not live with the person with dementia, they have to visit the person with dementia at least 3 times a week to be eligible for the study.
  • - The person with dementia must be living at home cared for by the caregiver.
  • - The person with dementia should have a diagnosis of dementia or experience severe cognitive impairments suggesting dementia.
Type of dementia is not an inclusion criterion.
  • - The person with dementia is not yet receiving formal care related to personal activities of daily living on account of his or her dementia more than once a week (defined by receiving assistance from a paid worker by e.g., health or social care professional as help with dressing/undressing; washing/bathing/showering; toileting; feeding/drinking; or taking medication).

Exclusion Criteria:

  • - Main exclusion criteria for both the caregiver and the person with dementia will be major mental or physical illness, such as major depression or stroke, that would affect their ability to participate in this study.
  • - Person with dementia or informal caregiver is participating in another intervention or similar support program.
  • - Dementia is caused by human immunodeficiency virus (HIV), acquired brain impairment, Down syndrome, chorea associated with Huntington's disease, or alcohol abuse.
  • - Inability to give informed consent will also be an exclusion criterion.
  • - Informal caregiver is younger than 18 years old.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06455163
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

VU University of Amsterdam
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Dementia, Mild
Arms & Interventions

Arms

Experimental: Eerder Erbij (intervention group)

Informal caregivers and people with dementia assigned to the intervention group will receive the 6-week intervention "Eerder Erbij".

No Intervention: Usual/standard care (control group)

Participants in the comparison condition will continue to receive usual care. Care for people with dementia in the Netherlands varies across municipalities, but the majority lives at home and especially earlier stages of the disease, most people living with dementia and their informal caregivers use no or very little formal care, apart from occasional visitors to GP or by case manager. The control group will be shared with another collaborating study from 'Maastricht University', which has the same goals, applies the same inclusion criteria, applies the same study procedures, and obtains the same outcomes. This implies that the data of the participants recruited for the control group for this study will be shared with the collaborating study.

Interventions

Other: - Eerder Erbij

The intervention (Eerder Erbij, EE) is a person-centred, manual-based intervention consisting of education, information and a support group for persons in the early stage of dementia and their main informal caregiver (e.g. spouse, relative), who receive little or no formal care. The intervention will discuss the effects of dementia, and how to cope and adjust to those effects. It will take place in small group sessions led by a health care professional (e.g. casemanager) and is intended for both the person with dementia and the caregiver. The intervention will be personalised to meet needs, interests and strengths of the dyad by discussing the sessions content at the start of the intervention.

Contact a Trial Team

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International Sites

Klinische Neuropsychologie, Amsterdam 2759794, North Holland 2749879, Netherlands

Status

Recruiting

Address

Klinische Neuropsychologie

Amsterdam 2759794, North Holland 2749879, 1081 BT

Site Contact

[email protected]

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